United States - English - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e antigen (unii: cob9ff6i46) (recombinant varicella zoster virus glycoprotein e antigen - unii:cob9ff6i46) - ge: recombinant varicella zoster virus (vzv) glycoprotein e 50 ug in 0.5 ml - shingrix is a vaccine indicated for prevention of herpes zoster (hz) (shingles):     •    in adults aged 50 years and older.     •    in adults aged 18 years and older who are or will be at increased risk of hz due to immunodeficiency or immunosuppression caused by known disease or therapy. limitations of use : do not administer shingrix to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of shingrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the data are insufficient to establish if there is vaccine-associated risk with shingrix in pregnant women. a developmental toxicity study was performed in female rats administered shingrix or the as01b adjuvant alone prior to mating, during g

United States - English - NLM (National Library of Medicine)

takeda pharmaceuticals amercia, inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2 ml - adynovate, antihemophilic factor (recombinant), pegylated, is a human antihemophilic factor indicated in children and adults with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes limitation of use adynovate is not indicated for the treatment of von willebrand disease. adynovate is contraindicated in patients who have had prior anaphylactic reaction to adynovate, to the parent molecule (advate), mouse or hamster protein, or excipients of adynovate (e.g. tris, mannitol, trehalose, glutathione, and/or polysorbate 80). risk summary there are no data with adynovate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with adynovate. it is unknown whether adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of adynovate in human milk, the effect on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adynovate and any potential adverse effects on the breastfed infant from adynovate or from the underlying maternal condition. safety and efficacy studies have been performed in 91 previously treated, pediatric patients age 1 year to <18 years who received at least one dose of adynovate as part of routine prophylaxis, on-demand treatment of bleeding episodes, or perioperative management. adolescent subjects age 12 to <18 (n=25) were enrolled in the adult and adolescent safety and efficacy trial, and subjects <12 years of age (n=66) were enrolled in a pediatric trial. the safety and efficacy of adynovate in routine prophylaxis and the treatment of bleeding episodes were comparable between children and adults. [see clinical studies (14) ] pharmacokinetic studies in children (<12 years) have demonstrated higher clearance, a shorter half-life and lower incremental recovery of factor viii compared to adults. because clearance (based on per kg body weight) has been demonstrated to be higher in children (<12 years), dose adjustment or more frequent dosing based on per kg body weight may be needed in this population. [see clinical pharmacology (12.3) ] clinical studies of adynovate did not include subjects aged 65 and over. adynovate [antihemophilic factor (recombinant), pegylated] (for intravenous use only) do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center. step-by-step instructions for reconstituting adynovate are found at the end of this leaflet. always follow the specific instructions given by your healthcare provider. the steps listed below are general guidelines for using adynovate. if you are unsure of the procedures, please call your healthcare provider before using. call your healthcare provider right away if bleeding is not controlled after using adynovate. your healthcare provider will prescribe the dose that you should take. reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. your healthcare provider may need to take blood tests from time to time. talk to your healthcare provider before traveling. plan to bring enough adynovate for your treatment during this time. dispose of all materials, including any leftover reconstituted adynovate product, in an appropriate container. - prepare a clean flat surface and gather all the materials you will need for the infusion. check the expiration date, and let the adynovate warm up to room temperature. wash your hands and put on clean exam gloves. if infusing yourself at home, the use of gloves is optional. - check the expiration date, and let the adynovate warm up to room temperature. - wash your hands and put on clean exam gloves. if infusing yourself at home, the use of gloves is optional. - open the adynovate package by peeling away the lid. remove the adynovate from the package and visually inspect the contents of the product and diluent vial. the adynovate powder should be white to off-white in color and the diluent should not contain particles. do not use if discoloration or particles are seen. - place on a flat surface with the diluent vial on top. the diluent vial has a blue stripe. - with one hand holding the adynovate housing, press down firmly on the diluent vial with the other hand until the system is fully collapsed and the diluent flows down into the adynovate vial. both vials will move into the housing when pressed. if you don't see the diluent transfer to the product vial, press the vials again to assure they are completely inserted. do not remove the blue cap until instructed in a later step. - swirl the adynovate gently and continuously until the adynovate is completely dissolved. do not shake . do not refrigerate after reconstitution . inspect the adynovate solution for particulate matter and discoloration prior to administration. the solution should be clear and colorless in appearance. if not, do not use the solution and notify your healthcare provider immediately. - take off the blue cap from the housing and connect the syringe. be careful to not inject air into the adynovate. - turn over the adynovate so that the vial containing the adynovate solution is on top. draw the adynovate solution into the syringe by pulling back the plunger slowly. if the solution does not draw into the syringe, be sure that both vials are pressed firmly together. the contents of more than one vial may be drawn into a single, appropriately sized syringe if you are using more than one vial of adynovate. - disconnect the syringe from the system. attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available. point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle. - apply a tourniquet and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your healthcare provider or hemophilia center). - insert the needle into the vein and remove the tourniquet. slowly infuse the adynovate. do not infuse any faster than 10 ml per minute. - take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes. - remove the peel-off label from blister lid and place it in your logbook. clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or any household disinfecting solution. - do not recap the needle. place needle, syringe and adynovate system in a hard-walled sharps container for proper disposal. do not dispose of these supplies in ordinary household trash. important: contact your healthcare provider or local hemophilia treatment center if you experience any problems. takeda pharmaceuticals u.s.a., inc. lexington, ma 02421 u.s. license no. 1898 adynovate® , advate® and baxject® are registered trademarks of baxalta incorporated. adynovate® is a registered trademark of baxalta incorporated. takeda® and the takeda logo® are registered trademarks of takeda pharmaceutical company limited. patented: see www.takeda.com/en-us/patents revised: 3/2023

United States - English - NLM (National Library of Medicine)

novo nordisk - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 500 [iu] in 1 ml - rebinyn, coagulation factor ix (recombinant), glycopegylated, is a recombinant dna-derived coagulation factor ix concentrate indicated for use in adults and children with hemophilia b (congenital factor ix deficiency) for: limitations of use : rebinyn is not indicated for immune tolerance induction in patients with hemophilia b. rebinyn is contraindicated in patients who have known hypersensitivity to rebinyn or its components (including hamster proteins) [see warnings and precautions (5.1) and description (11) ] risk summary there are no data with rebinyn use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with rebinyn. it is unknown whether rebinyn can cause fetal harm when administered to a pregnant woman or can affect fertility. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no informati

United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 25 [iu] in 1 ml - the use of recombinate [antihemophilic factor (recombinant)] is indicated in hemophilia a (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 recombinate is also indicated in the perioperative management of patients with hemophilia a (classical hemophilia). recombinate can be of therapeutic value in patients with acquired factor viii inhibitors not exceeding 10 bethesda units per ml.3   in clinical studies with recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 bethesda units per ml. however, in such uses, the dosage of recombinate should be controlled by frequent laboratory determinations of circulating factor viii levels as well as the clinical status of the patient. recombinate is not indicated in von willebrand’s disease. recombinate is contraindicated in patients w

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - recombinant cholera toxin b subunit 1mg; vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated); vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated); vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) - oral suspension - active: recombinant cholera toxin b subunit 1mg vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated) vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated) vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate dihydrate citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate - active immunisation of adults and children from two years of age, who will be visiting areas with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk. the vaccine should be considered for foreign aid workers and others intending to visit or spend an extended period of time in areas endemic or epidemic for cholera.

European Union - English - EMA (European Medicines Agency)

unigene uk ltd. - recombinant salmon calcitonin - hypercalcemia; osteitis deformans; bone resorption - calcium homeostasis - calcitonin is indicated for:prevention of acute bone loss due to sudden immobilisation such as in patients with recentosteoporotic fracturespaget's diseasehypercalcaemia of malignancy

European Union - English - EMA (European Medicines Agency)

pfizer limited - recombinant inactivated avian influenza virus - immunologicals - chicken; ducks - for active immunisation of chickens and ducks against avian influenza virus type a, subtype h5.chickens:reduction of mortality and virus excretion after challenge.onset of immunity: 3 weeks after the second injection.duration of immunity in chickens has not been established yet.ducks: reduction of clinical signs and virus excretion after challenge.onset of immunity: 3 weeks after the second injection.duration of immunity in ducks : 14 weeks after the second injection.

Israel - English - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 1000 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Israel - English - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 2000 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Israel - English - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 250 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.